Women's Heart Attack Research Program: Stress Ancillary Study

Women's HARP is a multi-center, observational study which enrolls women with MI who are
referred for cardiac catheterization. During the MI hospitalization, questionnaires will be
administered to assess psychosocial stress leading up to the event (MI). Participants will
also have the option to enroll in the HARP-Stress Ancillary Study and HARP-Platelet
Sub-Study. Two months following MI, participants may be screened for the Stress Ancillary
Study. Women with elevated perceived stress at screening will be enrolled. Patients will
complete baseline assessments (self-report questionnaires and 7 days of wrist actigraphy) and
then will be randomized to group-based stress management or to enhanced usual care (EUC).
Both study arms involve 8 weekly phone sessions delivered by trained facilitators. Following
intervention, participants in both study arms will repeat self-report questionnaires and 7
days of wrist actigraphy. Anticipate enrollment of approximately 200 women to meet target of
144 qualified women.

Inclusion Criteria:

- Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal
equivalent symptoms at rest or new onset exertional anginal equivalent symptoms

- Objective evidence of MI (either or both of the following):

- Elevation of troponin to above the laboratory upper limit of normal

- ST segment elevation of ≥1mm on 2 contiguous ECG leads

- Willing to provide informed consent and comply with all aspects of the protocol

- Age ≥ 21 years

- Female sex

- PSS-4 score ≥6 at 2 month follow up visit after MI

Exclusion Criteria:

- Alternate explanation for troponin elevation, such as hypertensive urgency, acute
exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary
embolism, cardiac trauma.

- Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)

- Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening)

- History of or current diagnosis of psychosis (EHR review)

- Significant cognitive impairment (EHR review or evident during screening)

- Current participation in another behavioral clinical trial.